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临床试验/NCT02485366
NCT02485366撤回4 期

Rejuvenated, Washed Packed Red Blood Cells in Pediatric Cardiac Surgery

Duke University1 个研究点 分布在 1 个国家开始时间: 2020年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
撤回
试验地点
1
主要终点
Change in tissue oxygenation/perfusion during cardiac surgery, measured by whole blood lactate concentration

研究概览

简要总结

Blood transfusion is nearly always needed during open heart surgery in children less than 15 kg (35 pounds). The purpose of the red blood cells in the blood is to deliver oxygen to the organs and tissues of the body. Stored blood undergoes some changes that may make it less effective in achieving this goal. The purpose of this study is to see if restoring important energy molecules (ATP and 2,3,DPG) in stored red blood cells before they are transfused, with a rejuvenating solution (Rejuvesol), offers any advantages to children over standard blood transfusion. This is a Food and Drug Administration (FDA) approved process that is described by the American Association of Blood Banks for prolonging blood storage but not used for everyday transfusions. The investigators want to use this process to improve blood transfused to children undergoing heart surgery.

Although Rejuvesol has been previously approved by the FDA, it is not routinely used to prepare standard blood transfusions to children undergoing surgery. Use of Rejuvesol in this study is considered investigational. This is a pilot study and data will be collected for future protocol development.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
— 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • children greater than 2.5 kg and less than 15kg (i.e. requiring blood for CPB prime)
  • children undergoing cardiac surgery with cardiopulmonary bypass

排除标准

  • refusal of blood products
  • end-stage renal disease
  • planned avoidance of CPB
  • use of non- heparin anticoagulants
  • participation in an experimental drug or device protocol within 30 days
  • existing hemoglobinopathy
  • allergy requiring washed RBCs
  • immunocompromise requiring special blood product treatment.

研究组 & 干预措施

Rejuvenated PRBCs

Experimental

The investigators will restore important energy molecules in stored red blood cells before they are transfused, with a rejuvenating solution (Rejuvesol).

干预措施: Rejuvesol (Drug)

Rejuvenated PRBCs

Experimental

The investigators will restore important energy molecules in stored red blood cells before they are transfused, with a rejuvenating solution (Rejuvesol).

干预措施: Cardiac surgery (Procedure)

结局指标

主要结局

Change in tissue oxygenation/perfusion during cardiac surgery, measured by whole blood lactate concentration

时间窗: End of Surgery

Change in ischemic organ injury during cardiac surgery, measured by urinary neutrophil gelatinase associated lipocalin (NGAL)

时间窗: 2 hours

Change in hemolysis during cardiac surgery, as measured by plasma free hemoglobin levels

时间窗: end of bypass

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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